About the procedure
A zonal system of authorisation operates in the EU to enable a harmonised and efficient system to operate.
The EU is divided into 3 zones; North, Central and South. EU countries assess applications on behalf of other countries in their zone and sometimes on behalf of all zones.
Regulation (EU) 1107/2009 sets out the requirements, procedure and timeframes for authorisation of Plant Protection Products (PPPs).
Applicants, EU countries, the European Commission and the European Food Safety Authority (EFSA) can be involved in the process of authorisation.
There are different types of application that can be submitted depending on the intended use of the PPP, the Member State(s) for which the PPP is required and the regulatory status of any existing authorisations. These are explained in further detail here:
First authorisation of a PPP
Articles 28-39 of Regulation (EU) 1107/2009 explain the requirements, contents and procedure for authorisation of PPPs.
Applications are evaluated on a zonal basis, but for some uses the EU is considered a single zone and a single Member State can evaluate a PPP on behalf of the entire EU.
These uses are:
- Greenhouse uses
- Post-harvest treatments
- Treatment of empty storage rooms or containers
- Seed treatments.
The basic procedure for authorisation of new Plant Protection Products (PPPs) and subsequent Mutual Recognition in other EU Member States is as follows:
- An application is made to the EU country/countries where the Plant Protection Product is intended to be placed on the market. A zonal Rapporteur Member State (zRMS) is selected for each zone where the PPP shall be authorised (some uses are assessed by a single Member States on behalf of all zones);
- zRMS carries out an assessment of the application;
- Other Member States in the same zone comment on the zRMS's evaluation;
- Zonal RMS makes a decision on whether to grant or refuse an authorisation;
- Other Member States make a decision to grant or refuse an authorisation;
- If an authorisation is issued and later the applicant wishes to place the same product on the market in another Member State(s), an application is made for 'mutual recognition' of the product in the concerned Member State.
Mutual Recognition
Mutual Recognition allows for the holder of an existing authorisation to apply for authorisation of the same PPP with the same use(s) and under comparable agricultural conditions.
Articles 40-42 of Regulation (EU) 1107/2009 explain the requirements, contents and procedure for Mutual Recognition. A Guidance Document provides details about the procedure.
Applications for Mutual Recognition can only be made if there is an existing authorisation for the PPP in another Member State.
Amendment or withdrawal of an existing authorisation
The same requirements and process as for first authorisation is followed for amendment to authorisation. Refer to the section on 'First authorisation of a PPP' for further details.
Applicants can choose to withdraw an authorisation at any time. A request to withdraw should be submitted to the relevant Member State.
Member States can review authorisations at any time if there are indications that the necessary requirements for authorisation are no longer met.
Renewal of authorisation
Following renewal of approval of an active substance, all plant protection products containing that active substance must also undergo a renewal assessment to make sure that products comply with the updated assessment of the active substance and with new scientific and technical knowledge. Renewals are carried out on a zonal level. Article 43 of Regulation (EU) 1107/2009 gives an overview of the process and timelines whilst an accompanying Guidance Document provides further specific details for this type of application.
Emergency authorisation
Article 53 of Regulation (EU) 1107/2009 provides for Member States to authorise, in special circumstances, the placing on the market of a PPP for a maximum period of 120 days and for limited and controlled use, where such a measure is needed to control a serious danger that cannot be controlled by any other reasonable means.
The Commission and all other Member States must be informed when an emergency authorisation is granted, and the Commission may ask the European Food Safety Authority for an opinion or scientific/technical assistance.
Applications for emergency authorisations should be made via the ESFC. The applications are made either by industry or by the Member State (in cases where the applicant is a grower, trade organisation or Member State local authority, for example).
A Guidance Document (under review) provides further details on what information must be provided to support an application.
Some parts of the application procedure are managed and handled outside of the ESFC by manual or electronic processes in the Member States.
The following Quick Reference Guides are handy tools to explain the process for submitting applications for emergency authorisation using ESFC:
- Quick Reference Guide for Member States: Processing applications for emergency authorisation
- Quick Reference Guide for Applicants: Processing applications for emergency authorisation
Application for Minor Uses
Article 51 of Regulation (EU) 1107/2009 allows for applications to be made to extend an existing authorisation to include minor uses not already covered by the authorisation. More information on the procedure can be found here.
Parallel trade permits
One of the key pillars of the European Union is the free circulation of goods within the internal market.
The free circulation of PPPs within the EU must be facilitated without posing any unnecessary barriers but at the same time safeguarding that the provisions in place do not pose any risk for human health, animals or the environment.
Parallel trade permits allow a product that is authorised in one Member State (origin MS) to be introduced into another Member State (introduction MS) if the Member State of introduction determines that an identical product is already authorised in its territory. A simplified procedure allows this to occur within 45 days.
Article 52 of Regulation (EU) 1107/2009 explains the process for applying for a parallel trade permit.
Three basic conditions must be met in order for a MS to grant a parallel trade permit:
- The plant protection product for which an application is submitted is authorised in the MS of origin and the reference product in the MS of introduction;
- The product from the MS of origin and the reference product in the MS of introduction are of identical composition
- An application is submitted in the MS of introduction
A Guidance Document is available which explains how applications for parallel trade should be carried out by Member States.
Assessment of technical equivalence
For the same active substance produced by different methods or from different sources, the level of hazard posed for health and the environmental must be comparable.
When the hazard from a new source is considered greater than the reference source a risk assessment must be performed to determine if PPPs containing the new technical material will fulfil the safety requirements laid down in Regulation (EU) 1107/2009.
Article 38 of Regulation (EU) 1107/2009 explains the process for the assessment of equivalence of active substances.
Guidance Document are available which explain how technical equivalence is conducted for chemical substances and microbial substances.
Under EU rules, it takes up to 1.5 years from the date of application to the granting, amendment or withdrawal of on authorisation. This time varies depending on how complex and complete the application is and the type of application.
How are applications for PPPs submitted?
Applicants who wish to have a PPP authorised in the EU must submit their applications to the relevant competent authorities in Member States according to the administrative requirements and submission systems in place in Member States.
Applications for emergency authorisations are submitted via the E-Submission for the Food Chain (ESFC) Platform, as explained above.
Member State procedural guidelines
Fees
EU country charge a fee to applicants to carry out the work required for evaluating an application.
Fees vary between EU countries. Further information is available directly from EU countries. You can find contact details here .
Draft Registration Report
All applications (new product, amendment and renewal) for PPPs should be made in the form of a draft Registration Report (dRR).
The dRR is split into 3 sections:
- Part A – risk management
- Part B – data evaluation and risk assessment
- Part C – confidential information
Further Guidance on the use of dRR can be found in the "Dossier and draft assessment report" part of the "Procedural guidance" section of the Guidelines page
Guidance
To learn more on how to prepare and submit applications, please go to Guidelines on Active Substances and Plant Protection Products.